AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Check against the official notice below — it lists the full affected range.
Biodex Medical Systems, Inc. is recalling the AtomLab 500Plus Dose Calibrator with software versions 2.0.00 through 2.0.08 (Model 086-332). When users delete a custom isotope from the device, the software removes the isotope but leaves the associated dial setting in place. This malfunction can cause other stored custom isotopes to have incorrect dial settings, potentially resulting in incorrect dose measurements or misadministration of medication. The recall affects 429 units with serial numbers ranging from 17080651 to 21061047, distributed nationwide and internationally across numerous countries.
The recalled devices were distributed across the United States and to 40 other countries including Canada, Mexico, the United Kingdom, Japan, and Australia. According to the recall record, no remedy is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Reason for recall: When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration Distribution: Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Sau Quantity: 429 units Lot/code info: Serial Number Range:17080651-21061047 UDI: 00718175003329
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.